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Assessment Report on Primula Veris L. And/Or Primula Elatior (L.) Hill, Radix

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Assessment Report on Primula Veris L. And/Or Primula Elatior (L.) Hill, Radix 19 September 2012 EMA/HMPC/113577/2012 Committee on Herbal Medicinal Products (HMPC) Assessment report on Primula veris L. and/or Primula elatior (L.) Hill, radix Based on Article 16d(1), Article 16f and Article 16h of Directive 2001/83/EC as amended (traditional use) Final Herbal substance(s) (binomial scientific Primula veris L., Primula elatior (L.) Hill, radix name of the plant, including plant part) Herbal preparation(s) A) Dry extract (DER 3-9:1), extraction solvent ethanol 40-50% v/v B) Liquid extract (DER 1:1), extraction solvent ethanol 70% v/v C) Liquid extract (DER 1:2.0-2.5), extraction solvent ethanol 70% v/v D) Tincture (ratio of herbal substance to extraction solvent 1:5), extraction solvent ethanol 70% v/v E) Soft extract (DER 5-10:1), extraction solvent water F) Soft extract (DER 1-4:1), extraction solvent ethanol 20-55% v/v G) Soft extract (DER 6-10:1), extraction solvent methanol, water, ammonia solution 10% (50.0:49.5:0.5) H) Soft extract (DER 6-10:1), extraction solvent methanol 50% I) Comminuted herbal substance Pharmaceutical form(s) Comminuted herbal substance as herbal tea for oral use. Other herbal preparations in liquid and solid dosage forms for oral use. Rapporteur R. Länger Assessor(s) R. Länger 7 Westferry Circus ● Canary Wharf ● London E14 4HB ● United Kingdom Telephone +44 (0)20 7418 8400 Facsimile +44 (0)20 7523 7051 E -mail [email protected] Website www.ema.europa.eu An agency of the European Union © European Medicines Agency, 2013. Reproduction is authorised provided the source is acknowledged. Table of contents Table of contents ................................................................................................................... 2 1. Introduction ....................................................................................................................... 3 1.1. Description of the herbal substance(s), herbal preparation(s) or combinations thereof .. 3 1.2. Information about products on the market in the Member States ............................... 6 1.3. Search and assessment methodology ..................................................................... 7 2. Historical data on medicinal use ........................................................................................ 7 2.1. Information on period of medicinal use in the Community ......................................... 7 2.2. Information on traditional/current indications and specified substances/preparations .... 7 2.3. Specified strength/posology/route of administration/duration of use for relevant preparations and indications ......................................................................................... 8 3. Non-Clinical Data ............................................................................................................. 12 3.1. Overview of available pharmacological data regarding the herbal substance(s), herbal preparation(s) and relevant constituents thereof ........................................................... 12 3.2. Overview of available pharmacokinetic data regarding the herbal substance(s), herbal preparation(s) and relevant constituents thereof ........................................................... 13 3.3. Overview of available toxicological data regarding the herbal substance(s)/herbal preparation(s) and constituents thereof ....................................................................... 13 3.4. Overall conclusions on non-clinical data ................................................................ 14 4. Clinical Data ..................................................................................................................... 14 4.1. Clinical Pharmacology ......................................................................................... 14 4.1.1. Overview of pharmacodynamic data regarding the herbal substance(s)/preparation(s) including data on relevant constituents ........................................................................ 14 4.1.2. Overview of pharmacokinetic data regarding the herbal substance(s)/preparation(s) including data on relevant constituents ........................................................................ 15 4.2. Clinical Efficacy .................................................................................................. 15 4.2.1. Dose response studies...................................................................................... 15 4.2.2. Clinical studies (case studies and clinical trials) ................................................... 15 4.2.3. Clinical studies in special populations (e.g. elderly and children) ............................ 15 4.3. Overall conclusions on clinical pharmacology and efficacy ........................................ 19 5. Clinical Safety/Pharmacovigilance ................................................................................... 19 5.1. Overview of toxicological/safety data from clinical trials in humans ........................... 19 5.2. Patient exposure ................................................................................................ 19 5.3. Adverse events and serious adverse events and deaths .......................................... 19 5.4. Laboratory findings ............................................................................................. 20 5.5. Safety in special populations and situations ........................................................... 20 5.6. Overall conclusions on clinical safety ..................................................................... 21 6. Overall conclusions .......................................................................................................... 21 Annex .................................................................................................................................. 21 Assessment report on Primula veris L. and/or Primula elatior (L.) Hill, radix EMA/HMPC/113577/2012 Page 2/21 1. Introduction 1.1. Description of the herbal substance(s), herbal preparation(s) or combinations thereof • Herbal substance(s) Primula root (Primulae radix) consists of the whole or cut, dried rhizome and root of Primula veris L. or Primula elatior (L.) Hill as described in the European Pharmacopoeia (European Pharmacopoeia 2008). Constituents (Hänsel et al. 1994, Wichtl 2004, Hänsel & Sticher 2007, Tschesche & Ballhorn 1975, Tschesche et al. 1983): The characteristic constituents are triterpene saponins (usually 3 – 10 [-12]%) and phenolic glycosides. The triterpene saponins are of the oleanane-type with branched sugar chains at the hydroxyl-group at the C-3. Saponins from Primula elatior are derived from the aglycone protoprimulagenin A, which is converted during acid hydrolysis to the artefact primulagenin A. The main saponin is called primulasaponin, it is characterised by a sugar chain consisting of glucuronic acid (Glu), glucose (Glc), galactose (Gal) and rhamnose (Rha). Minor saponins differ in the sugar chain (Hänsel & Sticher 2007). Main aglycones from the saponins of Primula veris are anagalligenin, priverogenin B and priverogenin B-22-acetate, important saponins are primacrosaponin (which has been isolated from Primula veris subsp. macrocalyx, Calis et al. 1992) and priverosaponin B. The haemolytic index (HI) has been used for biological standardisation of saponin containing herbal substances and herbal preparations. Although no longer in use the HI facilitates a comparison between the HI of a herbal substance and preparations thereof and allows an estimation of the saponin content. The HI of Primulae radix was defined in the Austrian Pharmacopoeia (ÖAB 9) with 3000. The phenolic glycosides primverin and primulaverin occur in both species in very variable amounts up to 2.3%, they are 2-primeverosides of 4-methoxy- and 5-methoxysalicilyc acid methyl esters (Thieme & Winkler 1971). These substances change during drying into the odoriferous aglycones (Wichtl 2004). Characteristic sugars of the underground organs are primverose (2-ß-(6-ß-Xylosido)-glucose, Hänsel & Sticher (2007) and the heptitol volemitol (= primulitol, Hegnauer 1969). The underground organs do not contain primin or other quinoid compounds, which are responsible for contact allergenic properties of aerial parts of species of the genus Primula (Hausen 1978). An overview on the chemical structures of important constituents is given in figure 1. H3C CH3 O O O CH3 CH3 CH3 O Primverose OH CH3 HO H3C CH3 OCH3 Protoprimulagenin A Primulaverin Assessment report on Primula veris L. and/or Primula elatior (L.) Hill, radix EMA/HMPC/113577/2012 Page 3/21 H3C CH3 O CH3 CH3 O O OH CH3 CH3 O Rha Gal Glu O Primverose H3C CH3 OCH3 Glc Primulasaponin Primverin H3C CH3 OH O OH CH3 CH3 OH OH H H CH 3 H HO HO Rha Gal Glu O HO OH H3C CH 3 H H Glc HO OH Primacrosaponin with the aglycone anagalligenin Volemitol H3C CH3 O OH CH3 CH3 OH CH3 Rha Gal Glu O H3C CH3 Glc Priverosaponin B with the aglycone priverogenin Figure 1: Chemical structures of important constituents of Primula root. • Herbal preparation(s) Herbal preparations with evidence of traditional use: A) Dry extract (3-9:1), extraction solvent ethanol 40-50% v/v; in the Austrian Pharmacopoeia (ÖAB) at least since 1960 a dry extract with a DER of 3-3.5:1 is included, the HI is specified with 9,000 – 11,000 (corresponding to a saponin content of approximately 25%). B) Liquid extract (1:1), extraction solvent ethanol 70% (m/m): in the Austrian Pharmacopoeia at least since 1960. HI 2,700 – 3,300 (corresponding to a saponin content of approximately 7.5%).
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